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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFLOSEAL HEMOSTATIC MATRIX
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namefusion matrix-dry
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP990009
Supplement NumberS013
Date Received11/18/2002
Decision Date03/10/2005
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an alternate kit configuration that contains a human thrombin component. The device, as modified, will be marketed under the trade name floseal hemostatic matrix and is indicated for use in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
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